Magnetic Resonance Imaging in Myocarditis

NCT02177630 | Completed

• 1 other identifier: 123456123456
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners

Conditions

Myocarditis

Keywords

myocarditis, myocardial inflammation, imaging, magnetic resonance

Outcome Measures

Primary Outcomes (1)

• Accuracy, sensitivity and specificity of magnetic resonance imaging sequences

  The diagnostic accuracy of individual and a combination of MR imaging sequences (late enhancement images, assessment of global edema, relative enhancement and T1 and T2 mapping sequences) will be determined by comparison to endomyocardial biopsies, which serve as diagnostic gold-standard

  baseline

Secondary Outcomes (1)

• Diagnostic performance of biventricular endomyocardial biopsies

  baseline

Study Arms (1)

Magnetic resonance imaging and endomyocardial biopsy

Magnetic resonance imaging and endomyocardial biopsy

Other: Endomyocardial Biopsy

Interventions

Endomyocardial Biopsy OTHER

Magnetic resonance imaging and endomyocardial biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinical suspicion of myocarditis

You may qualify if:

• Symptoms such as:
• Dyspnea or Orthopnea or
• Palpitations or
• Exercise intolerance or
• Angina
• Evidence of myocardial involvement:
• ventricular dysfunction on echocardiography or
• new or persistent ECG changes
• elevated Troponin T History of viral infection

You may not qualify if:

• Contraindication for magnetic resonance imaging
• Impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2
• Patients presenting with pregnancy
• Patients without informed consent
• Participation in another trial.

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead

Study Sites (1)

Heart Center of the University Leipzig

Leipzig, 04289, Germany

Location

Related Publications (2)

• Baessler B, Luecke C, Lurz J, Klingel K, Das A, von Roeder M, de Waha-Thiele S, Besler C, Rommel KP, Maintz D, Gutberlet M, Thiele H, Lurz P. Cardiac MRI and Texture Analysis of Myocardial T1 and T2 Maps in Myocarditis with Acute versus Chronic Symptoms of Heart Failure. Radiology. 2019 Sep;292(3):608-617. doi: 10.1148/radiol.2019190101. Epub 2019 Jul 30.

  PMID: 31361205 DERIVED

• Lurz P, Luecke C, Eitel I, Fohrenbach F, Frank C, Grothoff M, de Waha S, Rommel KP, Lurz JA, Klingel K, Kandolf R, Schuler G, Thiele H, Gutberlet M. Comprehensive Cardiac Magnetic Resonance Imaging in Patients With Suspected Myocarditis: The MyoRacer-Trial. J Am Coll Cardiol. 2016 Apr 19;67(15):1800-1811. doi: 10.1016/j.jacc.2016.02.013.

  PMID: 27081020 DERIVED

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Philipp Lurz, MD, PhD

  Heart Center of the University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator, Professor, Managing Senior Physician

Study Record Dates

• First Submitted: June 22, 2014
• First Posted: June 27, 2014
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

DE (1)